A Study to Investigate the Effect of Renal Function and Hemodialysis on the Pharmacokinetics (PK) of RO7079901



Status:Completed
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 80
Updated:12/13/2017
Start Date:December 20, 2016
End Date:July 6, 2017

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A Multi-Center, Open-Label, Two-Part Study to Investigate the Effect of Renal Function and Hemodialysis on the Pharmacokinetics of RO7079901

This is a multi-center, non-randomized, open-label, two-part study to investigate the effect
of renal function and hemodialysis on PK of RO7079901. Part 1 will be conducted in adult male
and female participants with stable mild, moderate or severe renal impairment and a control
group of participants with normal renal function. Part 2 will be conducted in adult male and
female participants with stable end-stage renal disease undergoing hemodialysis.


Inclusion Criteria:

- Body Mass Index (BMI) between 18 and 38 kilograms per square-meter (kg/m^2) and body
weight of at least 45 kilograms (kg)

Control group participants, Part 1 only:

- Normal renal function based on creatinine clearance greater than or equal to (>=) 90
milliliters per minute (mL/min) at the Screening visit

- Healthy for age-group, as determined by the investigator on the basis of medical
history, physical examination, clinical laboratory test results, vital signs, and
12-lead electrocardiogram (ECG)

Participants with renal impairment, Part 1 only:

- Reduced renal function based on estimated creatinine clearance at the Screening visit.
Creatinine clearance can be estimated from serum creatinine concentration at the
Screening visit using the Cockcroft-Gault equation, or be a historical measured value
obtained within the preceding 3 months. Participants with severe, moderate or mild
renal impairment must have creatinine clearance of less than or equal to (<=) 29, 30
to 59, or 60 to 89 mL/min, respectively

- Stable renal function. The stability of renal function will be confirmed by two
determinations of serum creatinine separated by at least 7 days (one of which can be a
historical value within the last 3 months). Renal function will be considered stable
if the 2 serum creatinine values differ by <=30 percent (%) of the lower value

Participants with end-stage renal disease in Part 2 only:

- Reduced renal function with a clinical diagnosis of end-stage renal disease requiring
renal replacement therapy

- Receiving hemodialysis for more than 3 months at the time of the Screening visit

Exclusion Criteria:

- Recipient of a renal transplant (Part 1 only)

- Presence of renal carcinoma, or acute renal disease caused by infection or drug
toxicity

- Nephrotic syndrome (defined as plasma albumin less than [<] 3 grams per deciliter
[g/dL] and/or proteinuria greater than [>] 3 grams per day [g/day])

- Hemoglobin concentration <10 g/dL, or <9 g/dL for participants with end-stage renal
disease

- Potassium concentration >5.5 millimoles per liter (mmol/L)

- Clinically significant liver disease

- Uncontrolled blood pressure

- Any condition associated with intra-vascular volume depletion

- Any unstable clinically significant disease

- Any other ongoing condition or disease (apart from renal dysfunction), or clinically
significant abnormalities in laboratory test results that the investigator considers
would render the participant unsuitable for the study, place the participant at undue
risk or interfere with the ability of the participant to complete the study

- Major surgery or significant traumatic injury <28 days prior to the first
administration (excluding biopsies), or anticipation of the need for major surgery
during study treatment

- Recent history of alcoholism, drug abuse, or addiction within the last year prior to
screening

- Positive test at Screening of any of the following: Hepatitis A, Hepatitis B,
Hepatitis C, or human immunodeficiency virus (HIV)

- Clinically significant change in disease status as judged by the investigator, or any
major illness within the 4 weeks prior to the Screening visit, or febrile illness
within 14 days prior to the Screening visit

- Use of prohibited medications, or alteration to a concomitant medication treatment
regimen considered relevant by the investigator within 14 days before the Screening
visit

- Known history of clinically significant hypersensitivity or severe allergic reaction
to any drug, in particular antibiotics (e.g., cephalosporins, penicillins,
carbapenems, or monobactams)

- Participation in another clinical study with an investigational drug or device within
the 1 month preceding the Screening vist

- Donation or loss of over 500 milliliters (mL) of blood within the 3 months before the
Screening visit
We found this trial at
5
sites
1000 Westgate Drive
Saint Paul, Minnesota 55114
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Saint Paul, MN
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825 South 8th Street
Minneapolis, Minnesota 55404
888-345-2567
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Minneapolis, MN
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5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
407-240-7878
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Orlando, FL
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Knoxville, Tennessee 37920
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Knoxville, TN
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Miami, Florida 33014
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Miami, FL
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